Patient Safety: Medical Device Distribution Evaluation and Sterile Barrier System Integrity

Transcription

1 Patient Safety: Medical Device Distribution Evaluation and Sterile Barrier System Integrity ASTM Work Shop, 11 October 2017 Jan Gates, VP Client Solutions, Adept Packaging Jane Severin, VP Technical Solutions, Network Partners

2 OBJECTIVE Present information on package distribution simulation and sterile barrier integrity testing Describe ASTM tests to assist in meeting regulatory and standards requirements 2

3 These slides are our opinions, based on our 60+ years experience, and not necessarily the opinion of the companies we represent. DISCLAIMER 3

4 AGENDA ISO /-2 Overview ISO /-2 Design and Validation Specifics Design and validations General requirements Process validations Packaging validations Test methods validations Microbial/whole package integrity Microbial testing Integrity Testing Shipping and Important Considerations The Last 1000 Feet Proposals 4

5 ISO /-2 STANDARDS Packaging For Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems Part 2: Validation Requirements for Forming, Sealing and Assembly Processes 5

6 ISO /-2 STANDARDS Outlines the packaging design, development and testing Over 150 shall statements in the two documents FDA harmonized with the standard in November

7 ISO /-2 VALIDATION SPECIFICS Validating a sterile barrier system involves four different types of validation activities: Design Packaging Process Sterilization Test Methods 7

8 ISO DESIGN Design The Packaging System shall be designed to minimize the safety hazard to the user and patient under the intended specified conditions of use. Accomplished with the use of risk assessment and mitigation techniques-output examples: Component and Process Specifications, process knowledge, user needs, etc. Develop pre-determined requirements for the design Validation provides objective evidence that the requirements have been met; design outputs = design inputs 8

9 ISO DESIGN VALIDATION Design Validation <definition> 3.28 validation (general) confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled. Consists of two elements - Industry practice to conduct these tests as independent studies Package Performance Testing - A physical evaluation to demonstrate that the packaging system is adequate to protect the product throughout distribution, handling and storage Stability Testing - A chemical and physical evaluation to demonstrate that the SBS maintains integrity over time. Basis for expiry claims. 9

10 TRANSPORTATION Will your design survive? Copyright 2013 DuPont. 10

11 DESIGN AND VALIDATION ARE KEY Examples of sterile packaging failures: Seal Creep Seal Failure Transport Damage 11

12 ISO PROCESS VALIDATION Process Validation <definition> 3.16 validation (process) documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. Provide documented, objective evidence that the packaging process is in statistical control, is repeatable, and makes product that meets predetermined specifications. IQ Installation Qualification - Verify equipment is correctly installed and functional, including all high and low settings OQ Operational Qualification - Defined process window (seal) PQ Performance Qualification - Adequate process control and capability 12

13 PACKAGING SYSTEM QUALIFICATIONS 13

14 EN ISO 11607: SECTIONS 1 TO 4 General Requirements Test Methods All test methods, including non-standardised ones, shall be validated and documented Note: ISO , Annex B contains a list of suitable test methods Test method validation shall include Rational for selection of appropriate tests Establishment of acceptance criteria Determination of repeatability (r) Determination of reproducibility (R) Establishment of sensitivity for integrity tests Needs interlaboratory check and comparison with published test method r & R 14

15 PACKAGE VALIDATION - ISO : : Porous materials shall provide an adequate microbial barrier to microorganisms in order to provide integrity of the sterile barrier system and product safety. 6.3 Packaging-system performance testing Integrity of the sterile barrier system shall be demonstrated after sterilization and subsequent performance testing Physical tests, along with microbial barrier testing of porous packaging materials, can be used to establish the capability of the sterile barrier system to maintain sterility In the absence of applicable validated tests (for the complete package), microbial barrier performance requirements can be established by testing: The microbial barrier properties of materials The integrity of seals and closures 15

16 TWO FUNDAMENTAL QUESTIONS Why is Microbial Barrier Important? The key factor in selecting packaging materials for medical devices is the ability of the package to maintain sterility from the point of sterilization until it is opened for use Why is Microbial Barrier Testing Important? Need to understand how the packaging material will perform as a microbial barrier during handling, distribution and storage; post sterilization 16

17 MICROBIAL BARRIER TESTING Traditional Whole Package Microbial Challenge HIMA Study comparing whole package test and physical tests o o o Dye and Visual Found a significant difference; Whole Package Challenge found to be unreliable and fraught with false-positives Hansen, J; Jones, L. et al (1995) In Quest of Sterile Packaging; Part 1 Approach to Package Testing MDDI 17(8) Current practice is to use material microbial testing for porous substrates and physical testing for finished packages o o ASTM F Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) ASTM F Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier 17

18 PACKAGE INTEGRITY TEST METHODS ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection 75 micron (60-100% Probability) ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Leak Test) Sensitivity Down to 250 micron ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Sensitivity Down to 50 micron 18

19 SENSITIVITIES ASTM Test Type of Test Test Focus Destructive? F1886 Visual Inspection Seals No 75 μm F1929 Dye Penetration Seals Yes 50 μm F2096 Internal Pressurization bubble test F2228 CO 2 tracer gas Package (porous area masked) F2338 Vacuum Decay Package (porous area masked) F3004 Airborne Ultrasound Hole/ Channel Size Package Yes 250 μm No No 50-l00 μm μm Seals No Depending on defect type (750 μm) 19

20 SHIPPING AND IMPORTANT CONSIDERATIONS 20

21 CALCULATING DIM L= length W = width H = height DIM = (L x W x H)/DIM ratio by carrier 21

22 PALLET/BOX STRENGTH CALCULATIONS 22

23 SIMULATED DISTRIBUTION TESTING ISTA 3A, 3B, and 3E are FDA Consensus Standards (2016) 23

24 SIMULATED DISTRIBUTION TESTING ASTM D4169 and D7386 FDA Recognized for many years Common Usage Standard Distribution Cycle Use ASTM D4169 DC 4 Single package with pallet or skid, LTL motor freight ASTM D4169 DC 13 Air (intercity) and motor freight (local, single package up to 150 lb. (61.8 kg). ASTM D4169 DC 2 Specially defined distribution system, user specified ASTM D7386 Not applicable* Assurance Levels I and II used Single parcel carrier shipments 24

25 HEALTHPACK LIVE POLLING

26 ORIGINAL DISTRIBUTION CONSIDERATIONS Manufacturer Plane Transit Manufacturer Hospital Use Manufacturer ASTM D4169 may have trucks, planes or trains in the transit ASTM D7386 single parcel shipment added 26

27 MORE CURRENT DISTRIBUTION LANE Manufacturer Hospital Use Manufacturer Product Manufacturer Home Trunk Stock Where does trunk stock occur? ASTM D4169 or D7386? More discussion later. 27

28 CASE FILL Full case of one product? Mixed product loads? Full pallet loads? Potential to bulk ship to one location (distributor) then individually or small quantity ship to another location (customer)? Last mile issues 28

29 MIXED LOAD SHIPPING 29

30 ONE SIMPLE U.S. DISTRIBUTION LANE Ship to hub Transfer/sorting hub Load truck Ship to airport Unload truck Ship to customer Load truck Stack in tarmac Unload plane Fly Load plane Stack in tarmac Unload truck Customer unloads shipper Prep product for use Use 30

31 DISTRIBUTION MAPPING DETAILED MULTIPLE SHIPPING COUNT EXAMPLE Domestic System and Domestic Repetition Round trip Handling Truck Transit Plane Transit Compression International System and International Repetition Round trip Handling Truck Transit Plane Transit Compression

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33 LAST 1000 FEET/LAST MILE Unexpected situations occurring before use Hospital Use 33

34 HEALTHCARE ASSOCIATED INFECTIONS CDC reports that the causal agent is not known for roughly 30% of HAIs in the US Could packaging materials be a contributor? What are the elements that medical device packaging are exposed to that could impact the barrier? Do you know what your product is exposed to in healthcare facilities once removed from shipping container? How do current test methods for microbial barrier provide meaningful data? 33 34

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44 PROPOSALS 1. Last 1000 feet investigation work group developed? Important for us to collaborate closely with healthcare Should an new work group be developed in ASTM for this work? Task force formed to evaluate whole package microbial testing? 2. Mixed load work group, D Currently being developed as an e-commence work group and subsections are possible Add drone shipping to the schedules? 3. Volunteers? Let us know.. 44

45 QUESTIONS? 45

46 CONTACTS Jan Gates Vice President, Client Solutions Phone/Cell: Website: Jane Severin, PhD, CPP Vice President, Technical Solutions Phone/Cell: Website: 46